歌礼宣布美国 IND 批准 ASC22（Envafolimab），一种皮下给药的 PD-

StephenW

歌礼宣布美国 IND 批准 ASC22（Envafolimab），一种皮下给药的 PD-L1 抗体，用于慢性乙型肝炎的功能性治愈

发布时间：2022 年 1 月 17 日

    估计美国有 159 万慢性乙型肝炎 (CHB) 患者。
    对中国慢性乙型肝炎患者进行的 IIb 期试验的中期结果显示，在基线乙型肝炎表面抗原（HBsAg）水平≤500 IU/mL 的患者中，治疗组约 19%（3/16）的患者获得 HBsAg安慰剂组 HBsAg 消失与无受试者在最后一次 ASC22 给药后没有反弹，表明乙型肝炎病毒 (HBV) 功能性治愈
    歌礼于2021年11月8日从苏州康宁杰瑞获得ASC22（Envafolimab）用于乙型肝炎和其他病毒性疾病的全球独家许可

杭州和中国绍兴，2022 年 1 月 17 日 /美通社/ -- 歌礼制药（港交所代码：1672）今天宣布美国食品药品监督管理局 (FDA) 批准研究性新药 (IND) 申请并启动全球开发ASC22 (Envafolimab) 是一种一流的皮下给药 PD-L1 抗体，用于功能性治愈慢性乙型肝炎 (CHB)。

2020 年 6 月发表的题为“美国慢性乙型肝炎病毒感染的患病率”的最新研究论文 [1] 显示，美国慢性乙型肝炎病毒 (HBV) 感染的总体估计患病率为 159 万患者（范围1.25–249 万）。世界卫生组织 (WHO) 和美国卫生与公众服务部 (DHHS) 都制定了正式的肝炎消除计划。

[1] Lim J K、Nguyen M H、Kim W R 等人。美国慢性乙型肝炎病毒感染流行情况[J].美国胃肠病学杂志 2020, 115(9): 1429-38。

ASC22 IIb 期研究（ClinicalTrials.gov 编号：NCT04465890）是一项在中国开展的随机、单盲、安慰剂对照、多中心临床试验，评估 149 名慢性乙型肝炎患者 24 周 1 mg/ kg 或 2.5 mg/kg ASC22 或匹配的安慰剂每两周一次 (Q2W) 与 NAs 联合给药。中期结果被美国肝病研究协会 (AASLD) 在 2021 年 The Liver Meeting® 的晚期休息会议上接受口头报告，结果显示，在基线乙型肝炎表面抗原 (HBsAg) 水平 ≤ 500 IU 的患者中/mL，治疗组中约 19% (3/16) 的患者获得 HBsAg 消失，而安慰剂组中没有受试者获得 HBsAg 消失，并且在最后一次 ASC22 给药后没有反弹，表明 HBV 功能性治愈。

ASC22对HBV功能性治愈的IIa和IIb期临床研究被AASLD审查委员会选入2021年“Best of The Liver Meeting's Summary”。这样的纳入是一项非凡的荣誉，表明 AASLD 审查委员会对歌礼在慢性乙型肝炎功能性治愈研究方面的高度评价。

歌礼宣布已于 2021 年 11 月 8 日获得苏州康宁杰瑞的全球独家许可，以开发和商业化用于包括乙型肝炎在内的所有病毒性疾病的 ASC22。歌礼预订所有病毒性疾病的 ASC22 的全球销售。

ASC22 是世界上最先进的临床阶段免疫疗法，通过阻断 PD-1/PD-L1 通路实现慢性乙型肝炎功能性治愈，即 HBsAg 消失。

“ASC22（Envafolimab）美国 IND 批准使我们能够启动 CHB 功能性治愈的美国和全球临床试验。同时，我们期待与 CHB 功能性治愈领域的行业领导者合作。”歌礼创始人、董事长兼首席执行官吴金子博士说。
关于歌礼

歌礼是一家在香港联交所（1672.HK）上市的创新研发驱动型生物科技公司，是一个覆盖从发现和开发到制造和商业化的整个价值链的全球平台。歌礼致力于在病毒性疾病、NASH/PBC 和癌症（口腔癌代谢检查点和免疫检查点抑制剂）领域开发和商业化创新药物，以解决中国和全球未满足的医疗需求。歌礼在一支拥有深厚专业知识和良好业绩的管理团队的带领下，以全球视角瞄准医疗需求未得到满足的治疗领域，高效推进管线开发，力争在全球竞争中处于领先地位。迄今为止，歌礼已拥有3个上市产品和20个具有全球竞争力的候选药物研发管线，并正在积极探索新的治疗领域。

1. 病毒性疾病： (1) 乙型肝炎病毒（功能性治愈）：专注于以皮下注射 PD-L1 抗体 ASC22 和 Pegasys® 作为基础药物的慢性乙型肝炎功能性治愈的突破性疗法。 (2) COVID-19 管线：目前包括 (i) 利托那韦口服片剂 (100 mg)，授权产品，(ii) ASC10，口服 RNA 依赖性 RNA 聚合酶 (RdRp) 抑制剂和 (iii) ASC11，口服 3-糜蛋白酶样蛋白酶 (3CLpro) 抑制剂。 (3) HIV/AIDS：ASC22，一种免疫疗法，用于恢复 HIV 特异性免疫反应并最终导致 HIV 感染患者的功能性治愈。 （4）丙肝：成功推出ASCLEVIR®和GANOVO®联合全口服方案（RDV/DNV方案）。

2、非酒精性脂肪性肝炎/原发性胆汁性胆管炎：歌礼全资公司Gannex致力于NASH领域新药的研发和商业化。 Gannex 拥有针对三种不同靶点的三种临床阶段候选药物——FASN、THRβ 和 FXR，三种针对 NASH 的固定剂量组合和一个针对 FXR 的 PBC 计划。

3. 癌症（口腔癌代谢检查点和免疫检查点抑制剂）：针对在癌症脂质代谢中起关键作用的FASN的口服抑制剂管线，以及口服PD-L1小分子下一代免疫检查点抑制剂管线。

4、探索性适应症：痤疮：继NASH和复发性GBM之后，ASC40的第三个适应症已获批进入2期临床试验。欲了解更多信息，请访问 www.ascletis.com。

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消息来源 Ascletis Pharma Inc.

StephenW

Ascletis Announces U.S. IND Approval of ASC22 (Envafolimab), a Subcutaneously Administered PD-L1 Antibody for Functional Cure of Chronic Hepatitis B

Published: Jan 17, 2022

    Estimated 1.59 million chronic hepatitis B (CHB) patients in the U.S.
    Interim results of the Phase IIb trial conducted on CHB patients in China showed that in patients with the baseline hepatitis B surface antigen (HBsAg) level ≤ 500 IU/mL, approximately 19% (3/16) of patients in the treatment group obtained HBsAg loss versus no subject achieved HBsAg loss in the placebo group and no rebound after the last dosing of ASC22, indicating hepatitis B virus (HBV) functional cure
    Ascletis obtained a global and exclusive license of ASC22 (Envafolimab) for hepatitis B and other viral diseases as of 8 November, 2021 from Suzhou Alphamab

HANGZHOU and SHAOXING, China, Jan. 17, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672) announces today the Investigational New Drug (IND) application approval by U.S. Food and Drug Administration (FDA) and initiation of global development of ASC22 (Envafolimab), a first-in-class, subcutaneously administered PD-L1 antibody for functional cure of chronic hepatitis B (CHB).

The recent research paper[1], titled "Prevalence of Chronic Hepatitis B Virus Infection in the United States" published in June 2020, showed an overall estimated prevalence for chronic hepatitis B virus (HBV) infection in the U.S. of 1.59 million patients (range 1.25–2.49 million). Both the World Health Organization (WHO) and U.S. Department of Health and Human Services (DHHS) have articulated formal hepatitis elimination plans.

[1] Lim J K, Nguyen M H, Kim W R, et al. Prevalence of Chronic Hepatitis B Virus Infection in the United States [J]. The American journal of gastroenterology 2020, 115(9): 1429-38.

ASC22 Phase IIb study (ClinicalTrials.gov Identifier: NCT04465890) is a randomized, single-blind, placebo-controlled, multi-center clinical trial in China which evaluates the efficacy and safety of 149 CHB patients for 24-week treatment of 1 mg/kg or 2.5 mg/kg ASC22 or matching placebo given once every two weeks (Q2W) in combination with NAs. Interim results, which were accepted for oral presentation in Late Breaking Session at The Liver Meeting® 2021 by the American Association for the Study of Liver Diseases (AASLD) showed that in patients with the baseline hepatitis B surface antigen (HBsAg) level ≤ 500 IU/mL, approximately 19% (3/16) of patients in the treatment group obtained HBsAg loss versus no subject achieved HBsAg loss in the placebo group and no rebound after the last dosing of ASC22, indicating HBV functional cure.

Phase IIa and IIb clinical studies of ASC22 for HBV functional cure were selected for inclusion in the "Best of The Liver Meeting's Summary" in 2021 by AASLD review committee. Such inclusion is a singular honor and indicates the high level with which the AASLD review committee regards Ascletis' research in CHB functional cure.

Ascletis announced it had obtained a global and exclusive license as of 8 November, 2021 from Suzhou Alphamab to develop and commercialize ASC22 for all viral diseases including Hepatitis B. Ascletis books sales globally for ASC22 of all viral diseases.

ASC22 is the most advanced clinical stage immunotherapy in the world for CHB functional cure, i.e. HBsAg loss, through blocking PD-1/PD-L1 pathway.

"ASC22 (Envafolimab) U.S. IND approval enables us to initiate U.S. and global clinical trials for CHB functional cure. Meanwhile, we are looking forward to collaborating with the industrial leaders in the field of functional cure of CHB." said Jinzi J. Wu, PhD, Founder, Chairman and CEO of Ascletis.
About Ascletis

Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), a global platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis is committed to developing and commercializing innovative drugs in the areas of viral diseases, NASH/PBC, and cancer (oral cancer metabolic checkpoint and immune checkpoint inhibitors) to address unmet medical needs both in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis targets those therapeutic areas with unmet medical needs from a global perspective, and efficiently advances the developments of pipelines with an aim of leading in global competition. To date, Ascletis has three marketed products and 20 robust R&D pipelines of drug candidates with global competitiveness, and is actively exploring new therapeutic areas.

1. Viral Diseases: (1) Hepatitis B Virus (functional cure): focus on breakthrough therapies for CHB functional cure with a subcutaneously-injected PD-L1 antibody – ASC22 and Pegasys® as cornerstone drugs. (2) COVID-19 pipeline: currently includes (i) ritonavir oral tablet (100 mg), an authorized product, (ii) ASC10, an oral RNA dependent RNA polymerase (RdRp) inhibitor and (iii) ASC11, an oral 3-chymotrypsin like protease (3CLpro) inhibitor. (3) HIV/AIDS: ASC22, an immune therapy to restore HIV-specific immune responses and eventually lead to a functional cure of HIV-infected patients. (4) Hepatitis C: successfully launched an all-oral regimen of combining ASCLEVIR® and GANOVO® (RDV/DNV regimen).

2. Non-alcoholic Steatohepatitis/Primary Biliary Cholangitis: Gannex, a wholly-owned company of Ascletis, is dedicated to the R&D and commercialization of new drugs in the field of NASH. Gannex has three clinical stage drug candidates against three different targets – FASN, THRβ and FXR, three fixed-dose combinations for NASH and one PBC program targeting FXR.

3. Cancer (oral cancer metabolic checkpoint and immune checkpoint inhibitors): a pipeline of oral inhibitors targeting FASN, which plays a key role in cancer lipid metabolism, and a pipeline of oral PD-L1 small molecule next generation immune checkpoint inhibitors.

4. Exploratory Indications: Acne: Following NASH and recurrent GBM, the third indication for ASC40 has been approved to enter Phase 2 clinical trial. For more information, please visit www.ascletis.com.

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SOURCE Ascletis Pharma Inc.